中国药房2017，Vol.28Issue(24)：3437-3440,4.DOI:10.6039/j.issn.1001-0408.2017.24.36
蔗糖铁注射液过滤除菌前配制液的微生物限度检查方法研究
Study on the Method of Microbial Limit Test for Preparation Liquid of Iron Sucrose Injection before Filtration and Sterilization
张永昕 1曾佳艳 2李莎恩 3俞发 2王振华 2李耿1
作者信息
- 1. 广州中医药大学中药学院,广州510006
- 2. 解放军第458医院,广州510602
- 3. 广东天普生化医药股份有限公司,广州510520
- 折叠
摘要
Abstract
OBJECTIVE:To establish a method of microbial limit test for liquid preparation of Iron sucrose injection before filtration and sterilization.METHODS:According to the microbial limit test in the "1005" and "general rules 1006" of 2015 edition of Chinese Pharmacopoeia (vol.Ⅴ),plate method and membrane filtration method were used to measure total number of aerobic bacteria (Staphylococcus aureus,Pseudomonas aeruginosa,Bacillus subtilis,Candida albicans,Aspergillus niger) and total number of molds and yeasts (C.albicans,A.niger).The optimal test method was obtained by comparing the bacterial recoveries.RESULTS:By plate method,the recoveries of P aeruginosa and B.subtilis were 2％ and 5％.The test sample was diluted 10 times with pH 7.0 sodium chloride-peptone buffer solution,and the bacterial recoveries were in the range of 88％ to 96％;but he medium was dark in color.By membrane filtration method,without rinse solution,the bacterial recoveries in the range of 88％ to 95％.Add rinse solution,the bacterial recoveries were in the range of 91％ to 103％.After validated,the recoveries of menbrane filtration method with tlushing fluid ranged 50％-200 ％,which was in line with the requnements.CONCLUSIONS:The membrane filtration method established in this experiment has higher bacterial recovery rate than the plate method.The bacterial recoveries rate were higher after adding rinse solution,and no dark substance in the surface of filter membrane affect the accotmt.It can be used as the microbial limit test method for preparation liquid of Iron sucrose injection before filtration and sterilization.关键词
蔗糖铁注射液/配制液/微生物限度检查/薄膜过滤法/平皿法Key words
Iron sucrose injection/Preparation liquid/Microbial limit test/Membrane filtration method/Plate method分类
医药卫生引用本文复制引用
张永昕,曾佳艳,李莎恩,俞发,王振华,李耿..蔗糖铁注射液过滤除菌前配制液的微生物限度检查方法研究[J].中国药房,2017,28(24):3437-3440,4.
